Expanded PrEP Implementation in Communities in NSW

Conditions

HIV, STI

Brief summary

A new NSW Ministry of Health HIV Strategy released on 1 December 2015 aims for the virtual elimination of HIV transmission in NSW by 2020. Critical to the new strategy's success is the population-based, targeted roll-out of HIV PrEP. PrEP involves taking one pill daily of co-formulated tenofovir disoproxil fumarate (TDF)/ emtricitabine (FTC). This large-scale study aims for the rapid roll-out of TDF/FTC to individuals at high risk of HIV, who will comprise mostly gay and bisexual men (GBM) but will also include small numbers of heterosexuals, injecting drug users, and transgender men and women. The drug will be used according to existing NSW Ministry of Health Guidelines. By rapidly rolling out this new intervention over a 12 month period, and following participants for two years on treatments, a reduction of about 50% in new HIV diagnoses in NSW is expected. The study aims to assess the incidence of HIV among PrEP study participants and measure the population-level impact of the rapid roll-out of PrEP on HIV diagnoses among GBM in NSW over a two-year period. It will also evaluate the rate of PrEP uptake among high risk GBM in NSW, assess the incidence of STI (gonorrhoea, chlamydia and infectious syphilis) among people prescribed PrEP and measure the effect of the rapid roll-out of PrEP on the overall number of notifications of gonorrhoea, chlamydia and infectious syphilis in NSW, describe patterns of PrEP use and medication adherence, and monitor behavioural risk practices among PrEP users. The main population group will be more than 3700 gay men at high risk of HIV infection. All procedures of this study are guided by the NSW Guidelines on PrEP. Protocol Co-Chairs Professor David Cooper, Professor Andrew Grulich. Project Manager: Barbara Yeung

Janaki Amin, Stefanie Vaccher, David J. Templeton, Benjamin R. Bavinton, Fengyi Jin et al. (15 authors)

Clinical Infectious Diseases2022-03-245 citations

10.1093/cid/ciac231

Long-term protection from HIV infection with oral HIV pre-exposure prophylaxis in gay and bisexual men: findings from the expanded and extended EPIC-NSW prospective implementation study.

Grulich AE, Jin F, Bavinton BR, Yeung B, Hammoud MA, Amin J, Cabrera G, Clackett S, Ogilvie E, Vaccher S, Vickers T, McNulty A, Smith DJ, Dharan NJ, Selvey C, Power C, Price K, Zablotska I, Baker DA, Bloch M, Brown K, Carmody CJ, Carr A, Chanisheff D, Doong N, Finlayson R, Lewis DA, Lusk J, Martin S, Ooi C, Read P, Ryder N, Smith D, Tuck Meng Soo C, Templeton DJ, Vlahakis E, Guy R, Expanded PrEP Implementation in Communities New South Wales (EPIC-NSW) research group.

2021-07-0173 citations

10.1016/s2352-3018(21)00074-6

Population-level effectiveness of rapid, targeted, high-coverage roll-out of HIV pre-exposure prophylaxis in men who have sex with men: the EPIC-NSW prospective cohort study.

Grulich AE, Guy R, Amin J, Jin F, Selvey C, Holden J, Schmidt HA, Zablotska I, Price K, Whittaker B, Chant K, Cooper C, McGill S, Telfer B, Yeung B, Levitt G, Ogilvie EE, Dharan NJ, Hammoud MA, Vaccher S, Watchirs-Smith L, McNulty A, Smith DJ, Allen DM, Baker D, Bloch M, Bopage RI, Brown K, Carr A, Carmody CJ, Collins KL, Finlayson R, Foster R, Jackson EY, Lewis DA, Lusk J, O'Connor CC, Ryder N, Vlahakis E, Read P, Cooper DA, Expanded PrEP Implementation in Communities New South Wales (EPIC-NSW) research group.

2018-10-17261 citations

10.1016/s2352-3018(18)30215-7

Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial.

Zablotska IB, Selvey C, Guy R, Price K, Holden J, Schmidt HM, McNulty A, Smith D, Jin F, Amin J, Cooper DA, Grulich AE, EPIC-NSW study group.

2018-02-0234 citations

10.1186/s12889-017-5018-9

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGTDF/FTC

one pill daily

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* HIV negative at enrolment, with a negative HIV test result documented within seven days of initiating PrEP * At high and ongoing risk for acquiring HIV infection through sexual exposure (as defined by Behavioural Eligibility criteria presented in Appendix II and online Risk Assessment Questionnaire in Appendix III), OR previously a PrELUDE study participant * Aged 18 years or over * Live in NSW or ACT or visit NSW or ACT enough to attend clinics for follow-up assessments * Willing and able to provide informed consent * Medicare ineligible individuals may be enrolled if the clinical service is able to cover the costs of monitoring of the patient

Exclusion criteria

* HIV-1 infected or has symptoms consistent with acute viral infection (If HIV positive status is not confirmed by testing, delay starting PrEP for at least one month and reconfirm negative HIV-1 status). * Having an estimated creatinine clearance (glomerular filtration rate \[GFR\]) \<60ml/min * Having or developing clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort, and weakness) * Concurrently taking a nephrotoxic agent (e.g., high-dose non-steroidal anti-inflammatory drugs / NSAIDs) * Allergic to TDF and/or FTC (based on self-report or recorded) * Concurrently taking prescribed products containing FTC or TDF including ATRIPLA®, COMPLERA®, EMTRIVA, STRIBILD®, VIREAD, TAF (tenofovir alafenamide), GENVOYA, DESCOVY; other drugs containing lamivudine; HEPSERA * Factors or conditions that may compromise a participant's access to health services for follow-up (incarceration or planned relocation and potential absence from NSW or ACT). Behavioural eligibility criteria as per NSW PrEP guidelines.

Design outcomes

Primary

Measure	Time frame
Incidence of HIV infection per 100 person years among study participants	24 months of follow-up
Number of HIV diagnoses among gay and bisexual men notified to the NSW Ministry of Health.	24 months of follow-up

Secondary

Measure	Time frame
Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants	24 months of follow-up

Countries

Australia

Outcome results

None listed